Clinical trial budgets

We commend Salim Yusuf for his reply¹ to the call by Lorraine Ferris and David Naylor² for additional monitoring of clinical trials. Yusuf's point on the increasing complexity of regulation for clinical trial research is well taken, as is the point that complying with complex regulations creates significant costs. Although one of us (J.A.C.D.) has previously argued against an excessive reliance on clinical trials,³ it is clear that they represent the modern gold standard. Given this reality, it is essential that we not choke off this important type of research.

Increasing costs through the requirement to deal with nontransparent and complex regulations actually makes it harder for independent researchers to do research. We have recently seen the consequences of restricting clinical trials to large drug companies⁴ rather than independent academic investigators. It would seem more appropriate to have well-trained auditors who could identify and rectify mistakes rather than merely increasing the burden of paperwork for researchers.

Ferris and Naylor rightly argue that their proposed measure is a reasonable addition to clinical trial monitoring in and of itself.⁵ However, too many individual straightforward and reasonable measures can result in a whole that is anything but. We agree with Yusuf that the correct direction is to reduce overhead costs and paperwork in the hope of making clinical trials more accessible.

J.A. “Chris” Delaney Statistician Royal Victoria Hospital McGill University Health Centre Montréal, Que. Andrei S.P. Brennan Research Ethics Quality Assurance Officer Research Institute McGill University Health Centre Montréal, Que.